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EC number: 225-268-8 | CAS number: 4748-78-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Safepharm Laboratories Limited, Shardlow Business Park, Shardlow, Derbyshire
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-ethylbenzaldehyde
- EC Number:
- 225-268-8
- EC Name:
- 4-ethylbenzaldehyde
- Cas Number:
- 4748-78-1
- Molecular formula:
- C9H10O
- IUPAC Name:
- 4-ethylbenzaldehyde
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark under nitrogen
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the solvent was dried using molecular sieves (sodium alumino-silicate) ie 2 mm pellets with nominal pore diameter of 4 x 10^-4 microns.
- Final dilution of a dissolved solid, stock liquid or gel: 50mg/ml DMSO
Method
- Target gene:
- his- (S. typhimurium), trp- (E. coli)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- E. coli WP2uvrA-
- Additional strain / cell type characteristics:
- DNA polymerase A deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitone/ β-naphthoflavone induced rat liver S9 in standard co-factors
- Test concentrations with justification for top dose:
- In order to select appropriate dose levels for use in the main test, a preliminary assay was carried out to determine the toxicity of the test material. The concentrations tested were 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate. The assay was performed on strains TA 100 and WP2uvrA-). Based on this assay the following concentrations were selected for the two mutation tests: 15, 50, 150, 500, 1500 and 5000 μg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: material immiscible in distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- In agar (plate incorporation);
- Cell density at seeding: range of 1 to 9.9 x 10^6 bacteria/mL
DURATION
- Exposure duration: 48h
- Expression time: 48h
SELECTION AGENT
minimal histidine or tryptophan
NUMBER OF REPLICATIONS:
3 in 2 independent experiments.
DETERMINATION OF CYTOTOXICITY
Growth of the bacterial background lawn
OTHER: Numbers of revertant colonies were determined using a Domino colony counter
- Evaluation criteria:
- The test material should have induced a reproducible, dose-related and statistically significant increase in reverent count in at least one strain of bacteria
- Statistics:
- Dunnett's method of linear regression
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA1535, TA1537, TA98, TA100, WP2uvrA-
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No
RANGE-FINDING/SCREENING STUDIES
The test material was toxic at 5000 μg/plate to both of the strains of bacteria used (TA100 and WP2uvrA) The test material formulation and S9-mix used in this experiment were both shown to be sterile.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The test material caused a visible reduction in the growth of the bacterial background lawn to all of the tester strains at 5000 μg/plate both in the presence and absence of S9-mix. The test material was, therefore, tested up to the maximum recommended dose level of 5000 μg/plate. - Remarks on result:
- other: no mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- The test material was considered to be non-mutagenic under the conditions of this test
- Executive summary:
In this study, according to the requirements of the OECD TG 471 and GLP principles, the mutagenic potential of the test substance was evaluated.
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA¯ were treated with the test material using the Ames plate incorporation method at six dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (Phenobarbitone/ β-naphthoflavone induced rat liver S9). The dose range for the range-finding study was determined in a preliminary toxicity assay and ranged between 0.15 and 5000 µg/plate with or without S9-mix. The experiment was repeated on a separate day using a similar dose range to the range-finding study, fresh cultures of the bacterial strains and fresh test material formulations. Additional dose levels were included in both experiments to allow for the toxicity of the test material, ensuring there were a minimum of four non-toxic doses. The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation. The test material was considered to be non-mutagenic under the conditions of this test.
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